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Adherence to GERD treatment, including medication, diet, and lifestyle, is essential for symptom control and complication prevention, yet adherence rates remain low due to various demographic and clinical factors. Digital therapeutics, particularly mobile health applications, have shown promising potential in supporting chronic disease management and improving patient outcomes.
The GERDCare mobile application was developed with direct input from gastrointestinal experts. It is designed to enhance treatment adherence and patient engagement by offering features such as educational resources, symptom tracking, medication reminders, and direct communication between patients and physicians.
The investigators are conducting a single-center, open-label, randomized controlled trial to evaluate the effectiveness of using GERDCare in improving patient adherence. Patients are followed up after four weeks of GERD treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Using GERDCare | Experimental | Using the mobile phone application GERDCare (with detailed instructions provided during recruitment) |
|
| Not using GERDCare | No Intervention | Not using the smartphone application GERDCare |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GERCCare mobile app | Other | Using the smartphone application GERDCare (with detailed instructions provided during recruitment) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with good adherence at 4 weeks | Patients achieved a score of ≥27 points on the Vietnamese Version of the General Medication Adherence Scale (GMAS). Higher scores mean better adherence. | 4 weeks after recruitment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in GERD symptom severity | GERD symptom severity evaluated by the Gastroesophageal Reflux Disease Questionnaire (GerdQ) Score. The score has a minimum value of 0 and a maximum value of 18. High scores present more severe GERD symptoms. Value ≥ 8 means high probability of GERD. | 4 weeks after recruitment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Binh Phuc Nguyen, MD | Contact | +84356665787 | binhnguyen.fsh@gmail.com | |
| Hang Viet Dao, MD, PhD | Contact | +84987988075 | hangdao.fsh@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Gastroenterology and Hepatology | Recruiting | Hanoi | 100000 | Vietnam |
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| Proportion of patients with clinical improvement after 4 weeks |
Symptom resolution evaluated clinically |
| 4 weeks after recruitment |
| Changes of patients' quality of life after 4 weeks | Patient's quality of life evaluated by the GERD Quality of Life (GERD-QoL) score. It is an 18-item questionnaire grouped into four subscales (Daily activity, Treatment effect, Diet, and Psychological well-being). The total score was converted to a scale of 0-100, in which 100 means high influence on quality of life caused by GERD symptoms. | 4 weeks after recruitment |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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